MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 37603 |
Device Problems
Break (1069); Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 3389s-40, serial/lot #:(b)(4), ubd: 27-feb-2021, udi#: (b)(4).All codes are associated with the lead, as the ins had no known complaint at this time.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that during the stage two procedure, the lead end cap was removed to be connected with the extension.Upon removal of end cap, a small "coil" was "pulled out at the end of the lead (contact 3)".The surgeon used force to place the coil back in the lead and connected it to the extension.Impedance tests were performed twice during the procedure and they were within normal limits.The procedure proceeded as usual.No environmental/external/patient factors were known.The surgeon placed a piece of coil back into the lead.The issue was resolved at the time of the report.No patient symptoms or further complications were reported as a result of this event.
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Search Alerts/Recalls
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